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Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Study acronym: CODEX
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Study sites: 6 to 8v7
  2. Primary completion date: Mar 2026 to Jul 2028v6 Show 5 more changesShow less
    • Study sites: 1 to 6
    • Study completion date: Mar 2026 to Mar 2029
    • Eligibility criteria expanded, about 9 words
    • Collaborators: 3 to 11
    • Study description expanded, about 2 words
  3. 3 versions Re-verified since Nov 5, 2020, no change to tracked fieldsv3-v5
  4. Start date: Mar 11, 2019 to Dec 1, 2019
    • Primary and study completion dates: Mar 11, 2026 to Mar 2026
    • Eligibility criteria revised
    • Site contact updated
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.
Trial Details
NCT Number NCT04289142
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: London Health Sciences Centre, University Health Network, Toronto, McMaster University, Canadian Institutes of Health Research (CIHR), The Dana Foundation, Brain Canada, Alzheimer's Association, Hamilton Health Sciences Corporation, University of Saskatchewan, Fraser Health, Providence Health & Services
Conditions
(from sponsor)		 Delirium, Cognitive Dysfunction, Cognition Disorder, Neurocognitive Disorders, Mental Disorders, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations +9 more
Related terms Cognition Disorders, Cognitive Dysfunction, Confusion, Delirium, Mental Disorders, Nervous System Diseases, Neurobehavioral Manifestations, Neurocognitive Disorders, Neurologic Manifestations, Signs and Symptoms
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov